U-LABA/ICS Effects on Exercise Performance, Formoterol

Sponsor

University of Copenhagen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06105671

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

Condition or Disease	Intervention/Treatment	Phase
Exercise Performance	Drug: Symbicort Drug: Formoterol Drug: Formoterol Drug: Placebo Drug: Mannitol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Symbicort - usual care Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.	Drug: Symbicort Participants are administered 54 μg Formoterol and 1920 μg Budesonide
Experimental: Formoterol - inhalation Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.	Drug: Formoterol Participants are administered 54 μg Formoterol from an inhaler device
Experimental: Formoterol - oral Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.	Drug: Formoterol Participants are administered 54 μg Formoterol in a capsule, which is taken orally
Placebo Comparator: Placebo Participants are administered placebo from an inhaler device testing and a placebo capsule.	Drug: Placebo Participants are administered placebo
Experimental: Mannitol-test Participants are administered Bronchitol from an inhaler device testing.	Drug: Mannitol Participants are administered 600 mg Bronchitol

Outcome Measures

Primary Outcome Measures

Power output during time trial [Through study completion, an average on 4 weeks]
Mean power output measured in Watts during a time trial on a bike ergometer

Secondary Outcome Measures

Power output during sprint testing [Through study completion, an average on 4 weeks]
Power output measured in Watts during a sprint on a bike ergometer

Other Outcome Measures

Quadriceps strength [Through study completion, an average on 4 weeks]
Maksimal torque (Nm) achieved during isometric contraction
Forced Expiratory Volume in 1 second (FEV1) [Through study completion, an average on 4 weeks]
FEV1 measured by spirometry
Respiratory muscle function [Through study completion, an average on 4 weeks]
Mouth inspiratory and expiratory pressures against a closed system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 18-45
Physically active >5 hours a week
Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
ECG abnormality
FEV1/FVC ratio < 0,7 determined with spirometry
Chronic illness determined to be a potential risk for participant during the study
In chronic treatments with medication that may interfere with study results
Pregnancy
Smoker
Blood donation during the past 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	August Krogh Building	Copenhagen		Denmark	2100

Sponsors and Collaborators

University of Copenhagen

Investigators

Principal Investigator: Morten Hostrup, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT06105671

Other Study ID Numbers:

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mannitol

Formoterol Fumarate

Budesonide, Formoterol Fumarate Drug Combination

Study Results

No Results Posted as of Oct 30, 2023